Guidance and COVID Updates

Changes to Recruitment and Consenting Processes during the COVID-19 Pandemic

Current Recruitment or Consenting Process approved for your study by the REB (Traditional Process)	Alternative Recruitment or Consenting Process Options during COVID-19
Options Permitted for Minimal Risk Studies ONLY
In-person written consent	Moving to remote Verbal Consent (participant verbally consents to participate; no signature is collected) See the following documents for detailed information: Guidance on Verbal Consenting Process Instructions for Moving from an In-Person Written Consent to Verbal Consent for minimal risk studies only during the Pandemic OHRI Verbal Telephone Consent Script Template Video Link to Learning Session (coming soon)
Options Permitted for ALL Studies
In-person written consent	Moving to virtual/remote consent discussion (i.e., videoconference or telephone) and virtual/remote signature (i.e., mail, fax, email, REDCap, DocuSign, Adobe Sign) Guidance for Remote Recruitment and Consenting via Video Platform Guidance for In-Person Written Consent Moving to Virtual/Remote Consent and Virtual/Remote Signature Guidance for Remote Consenting Process with the Use of Impartial Witness (including witness signature page) For studies greater than minimal risk using remote telephone consent instead of video platform due to participant not being able to connect via video platform. View the following instructions on sending and receiving study information to/from participants: Communicating with Participants via Email: Guidance for Obtaining Consent from Participants to Communicate by Email Consent Form: Research Participant Consent to Communicate by Email - English \| French Guidance for Use of Email in Clinical Research Instructions for Use of Microsoft 365 SharePoint and OneDrive The Ottawa Methods Centre Electronic Data Capture system (EDCS) Video Link to Learning Session (coming soon) Guidance for Use of Mail Guidance for Use of Scan/Fax Video Link to Learning Session (coming soon) For information on sending and receiving study information to/from participants via IT platforms, please see section below.
In-person written consent	Moving to in-person consent discussion, with the use of an impartial witness in place of participant signature See the following documents for detailed information: Guidance for In-Person Consenting Process with the use of an Impartial Witness Form: In-Person Consenting with Impartial Witness Process Checklist Form: Impartial Witness Addendum to Consent Signature page Video Link to Learning Session (coming soon)
In-person written consent	Moving to in-person consent discussion, with collection of participant signature in an appropriate IT/IS approved platform, such as REDCAP, DocuSign or Adobe Sign (coming soon) Researchers may use REDCAP, DocuSign or Adobe Sign for consent purposes. See the following documents for detailed information: REDCap e-Consenting Instructions REDCap e-Signature Guidance Guidance for Use of DocuSign (coming soon) Guidance for Use of Adobe Sign (coming soon) Other (coming soon) Note: REDCap currently can only be used internally as it is behind the TOH and/or UOHI firewall and consent cannot be collected from participants for regulated studies as the signature is not validated in REDCap. There are costs associated with the use of DocuSign and Adobe Sign. If you would like to use other electronic platforms, please contact REBAdministration@toh.ca to set up a meeting with the REB Manager and REB Chair/Vice-Chair Video Link to Learning Session (coming soon)